Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI

NCT06564909 | Recruiting Phase 2

• 1 other identifier: RHDIRB2020110301 REC #268
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker

Conditions

Reperfusion Injury, Myocardial; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Evaluation of the marker nitrotyrosine

  Measuring serum concentration of nitrotyrosine as an oxidative stress marker

  24 hours post PCI

• Evaluation of the marker (MMP-2)

  Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.

  24 hours post PCI

Secondary Outcomes (5)

• Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow

  0-1 hour at the end of PCI

• Assessment of Myocardial Blush Grade

  0-1 hour at the end of PCI

• Incidence of ST-segment resolution >70 by ECG

  60 minutes post PCI

• Echocardiography

  4 weeks

• Occurrence of Major Adverse Cardiac Events (MACE)

  4 weeks

Study Arms (2)

Control group

EXPERIMENTAL

38 STEMI patients undergoing PCI who will receive the standard of care for 4 weeks and will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants and anti-ischemic measures (high intensity statin, ACEI or aldosterone) as per latest guidelines recommendations.

Drug: The standard care for the management of myocardial infarction post PCI

Test group

EXPERIMENTAL

38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI

Drug: L-Carnitine; Drug: The standard care for the management of myocardial infarction post PCI

Interventions

L-Carnitine DRUG

L-Carnitine 5 g intravenous administered as slow IV push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) and Carnitol 500 mg® Oral, Global Napi, Egypt)

Also known as: levocarnitine

Test group

The standard care for the management of myocardial infarction post PCI DRUG

include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.

Also known as: Guideline-directed medical therapy for STEMI

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male aged \>18 and \< 75 years.
• STEMI patients undergoing PCI.

You may not qualify if:

• Patients with a recent history of myocardial infarction (MI), a previous PCI, a previous coronary artery bypass graft, or any cardiac surgery.
• A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure),
• Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI,
• Concurrent Infectious or active inflammatory disease,
• Severe liver or renal disease, (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3x ULN or Total bilirubin \> 3 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
• Neoplasm, or hematological disorders
• Pregnant or breast-feeding patients
• Active participation in another clinical study
• Patients taking antioxidant drugs.
• History of or known allergy or intolerability to the study medications

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Reperfusion Injury; Myocardial Infarction

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Central Study Contacts

Mohamed Hamdy Mohamedy

CONTACT

+201151189985; mohamed.hamdy.mh@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at clinical pharmacy department

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 21, 2024
• Study Start: June 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

EG (1)